Mendus Q3’24 preview: New ilixadencel trial preparations underway

Mendus will release its Q3 results on Friday, November 8, at 8:00 am CET. The live presentation and business update starting at 2:00 pm can be viewed here. The main announcement during the quarter was to bring ilixadencel back into clinical development for soft-tissue sarcomas. Patient enrollment has also started for the all-important Phase II CADENCE trial for acute myeloid leukemia (AML). With the funding secured, the company should have the necessary building blocks to achieve a data readout of the CADENCE trial in mid-2025 as well as to finalize building readiness for a pivotal-stage trial for AML by H2’25.

New ilixadencel clinical trial in preparation for soft tissue sarcomas

During the quarter, Mendus announced that ilixadencel will return to the clinical arena after a period of strategic consideration. Ilixadencel will be evaluated in a new trial in collaboration with the French cancer center Institut Bergonié. The trial will combine ilixadencel with the anticancer drugs regorafenib and avelumab in soft tissue sarcomas. The company expects preparations for the trial to be completed in H2’24 and an initial data readout in H1’26.

Mendus’ lead clinical development is the CADENCE trial (formally AMLM22-CADENCE), which we understand has recently started enrolling patients. The trial is being conducted in collaboration with the Australasian Leukaemia and Lymphoma Group (ALLG). CADENCE combines Mendus' lead asset, vididencel, with the standard of care oral azacitidine for AML maintenance therapy. Mendus plans to report data in mid-2025. The company is also building readiness for pivotal trials, including upscaling manufacturing of vididencel in partnership with NorthX. We believe these goals are achievable with the financing already in place. Mendus' cash runway is until Q3'25, strengthened by a 317 MSEK financing round in summer 2023 and the exercise of warrants in Q2’24.

On the financial side we expect an EBIT of -31.1 MSEK (Q3'23: -25.9 MSEK). The loss is expected to be slightly higher than in Q2’23 due to lower-than-average R&D costs compared to last year.

Q4 focus on start of CADENCE trial and readout of ALISON trial in ovarian cancer

If successful, vididencel could build long-lasting immunity against cancer and help extend disease-free and overall survival. In 2024 this target is mainly driven by the CADENCE trial. Current preparations for pivotal readiness could mean that a registration trial could start in late 2025-early 2026, although this estimate is subject to significant uncertainty. We also expect to see data from the Phase I ALISON trial in 2024. In our long-term estimates, we expect vididencel for AML to be launched in 2029, with further launches to follow in 2030 and 2031. For more detailed information, see our recent Initiation of coverage report.